The following data is part of a premarket notification filed by Cardiorhythm with the FDA for Voyagr Series Diagnostic Ep Catheters.
| Device ID | K923916 |
| 510k Number | K923916 |
| Device Name: | VOYAGR SERIES DIAGNOSTIC EP CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CARDIORHYTHM 90 WEST PLUMERIA DR. San Jose, CA 95134 |
| Contact | George M Savage |
| Correspondent | George M Savage CARDIORHYTHM 90 WEST PLUMERIA DR. San Jose, CA 95134 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-28 |
| Decision Date | 1993-02-10 |